Quality Specialist - P1
Boston Scientific
- Dorado, PR
- Permanente
- Tiempo completo
- Support departmental or cross-functional quality initiatives or projects by applying technical and quality system principles.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, investigating and resolving quality issues.
- Assist site's leadership in the collection, review, trending and/or reporting of quality data in support of Management Review.
- Provide direction and mentoring to CAPA/NCEP owners, including timely tracking, follow up and closure of NCEPs/CAPAs in their different phases.
- Interpret applicable internal and external regulatory requirements, regulations, and standards, as applicable.
- Participate cross functionally in global quality system projects and/or harmonization initiatives.
- Participate in internal and/or external audits as required by Management.
- Educate functional areas on quality system requirements.
- Other duties as necessary or required by the department or site.
- Bachelor’s Degree in science or Engineering preferred and 3+ years of related work experience.
- Experience working in manufacturing area, Neuromodulation preferred.
- Understanding of product design concept with applicability on manufacturing environment.
- Knowledge in Quality Systems and Identification Traceability Systems (e.g. eCAPA, Windchill, MES, SAP, IQS, etc).
- General knowledge in quality metrics.
- Experience in problem solving activities, identification of root causes and understanding corrective and preventive actions.
- Willing to work different shits (1st, 2nd, 3rd and/or weekends) as needed
- Fully Bilingual